Pembrolizumab in Locally Advanced Sinonasal Carcinoma

ConditionSinonasal Undifferentiated Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC).

Activity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.

Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.

Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.

Be ≥ 18 years of age on day of signing informed consent.

Disqualifiers

Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).

2. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.

A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

Trial design

Design model

Single group

Treatments tested in this trial

Pembrolizumab
Drug
Pembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care
Cisplatin
Drug
Cisplatin 75mg/mq in combination with pembrolizumab 200 mg and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses.
Docetaxel
Drug
Docetaxel 75 mg/mq in combination with pembrolizumab 200 mg and cisplatin 75 mg/mq every three weeks (Q3W) for 3 courses.
Carboplatin
Drug
Carboplatin AUC 5 alternative to Cisplatin if toxicities occur.

Treatment groups

28 Participants

are divided into 1 treatment group

Group A: Neoadjuvant PembrolizumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Neoadjuvant therapy objective response rate (ORR)

ORR defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1

Time frame

Up to 24 months after the end of neoadjuvant treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov

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